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Advanced in vitro methods in generic drug product development
Webinar
Zentiva is a generics manufacturer that is developing innovative processes to manufacture APIs, and to formulate the drug product itself. It is using Pion instruments to better understand the API molecule’s behavior in-vivo and any potential risks to progression are critical in the development of new generic medicines. In this webinar the following topics will be covered:
- Physicochemical characterization of APIs using Pion’s SirusT3
- Screening of API solid forms using InForm
- Precipitation experiments on InForm – screening of precipitation inhibitors and description of factors influencing repeatability of the experiments
- MacroFlux – indirect identification of API-excipient interactions and risk mitigation for bioequivalence studies
- Rainbow fiber optic system – use for precipitating systems, comparison with standard offline analysis (UV/HPLC)